| CTRI Number |
CTRI/2025/05/086312 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Changes in protein levels in saliva of patients treated with invisible braces and metal braces |
|
Scientific Title of Study
|
Changes in the levels of apolipoprotein E in saliva during clear aligner therapy and fixed orthodontic treatment |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sourav Hari |
| Designation |
Post Graduate |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College Department no.3 ground floor School
of Dental Sciences MRIIRS Surajkund Road Faridabad
Faridabad
HARYANA
121003
India
Manav Rachna Dental College Department no.3 ground floor School
of Dental Sciences MRIIRS Surajkund Road Faridabad
Faridabad
HARYANA
121003
India
Faridabad
HARYANA
121004
India |
| Phone |
7907069870 |
| Fax |
|
| Email |
souravputhur98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Kumar Singh |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Room no 3 Department of Orthodontics and Dentofacial Orthopedics Manav Rachna Dental College School of Dental Sciences Sector 43 Delhi Surajkund Badkal Road faridabad
Faridabad
HARYANA
121004
India |
| Phone |
8377878380 |
| Fax |
|
| Email |
aksingh.sds@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Kumar Singh |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Room no 3 Department of Orthodontics and Dentofacial Orthopedics Manav Rachna Dental College School of Dental Sciences Sector 43 Delhi Surajkund Badkal Road faridabad
Faridabad
HARYANA
121004
India |
| Phone |
8377878380 |
| Fax |
|
| Email |
aksingh.sds@mrei.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sourav Hari |
| Address |
Manav Rachna Dental College School of Dental Science Sector 43 Delhi Suraj Kund Badkal Road Faridabad |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sourav Hari |
Manav Rachna Dental College |
Room no 3 Department of Orthodontics and Dentofacial Orthopedics Manav Rachna Dental College Sector 43 Delhi Suraj Kund Badkal road Faridabad
Faridabad
HARYANA |
7907069870
souravputhur98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clear Aligners |
Assessment of levels of Apolipoprotein E in salivary samples of patients undergoing treatment with clear aligners |
| Comparator Agent |
Fixed Orthodontic Treatment |
Assessment of levels of Apolipoprotein E in salivary samples of patients undergoing fixed orthodontic treatment |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
a)Age group from 15-30 years
b) Bimaxillary protrusion cases that require extraction of all premolars for orthodontic correction.
c) No history of antibiotics and anti-inflammatory drugs in past 6 months preceding study.
d) Periodontally healthy with generalized probing depth less than or equal to 3 mm.
e)Radiographic parameters of no signs of crestal bone loss on radiograph.
|
|
| ExclusionCriteria |
| Details |
Presence of gingivitis and periodontitis
b) Presence of Systemic disease
c) Presence of bone disease
d) History of previous orthodontic treatment
e) Smoking habit
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the level of Apolipoprotein E |
T0- Saliva collected at beginning of treatment
T1 - Saliva collected 24 hours after intervention.
T2- Saliva collected after 21 days of intervention
T3 – Saliva collected after 6 months of
intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare both the groups |
T0- Saliva collected at beginning of treatment
T1 - Saliva collected 24 hours after intervention.
T2- Saliva collected after 21 days of intervention
T3 – Saliva collected after 6 months of
intervention |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [souravputhur98@gmail.com].
- For how long will this data be available start date provided 01-05-2025 and end date provided 25-02-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This prospective study aims to assess changes in biomarker Apolipoprotein E in salivary samples of patients undergoing treatment with clear aligners and fixed orthodontic treatment. Clear aligners, which are a newer orthodontic treatment modality, have not been explored extensively for changes
in biologic mediators with the application of orthodontic forces.
A long-term assessment of changes in biomarkers in biological fluids can provide evidence of changes at the biological level and its efficacy when compared to conventional fixed orthodontic treatment.
The study will comprise of 32 patients of age group 15- 30 years willing to undergo orthodontic
treatment with clear aligners and fixed orthodontic treatment. The salivary samples of 16 patients with bimaxillary protrusion from each group, who have been subjected to extraction of
all premolars, will be collected before beginning the treatment, 24 hours after intervention, 21 days
after intervention, and after 6 months of intervention. |